JPRN-jRCT2080224507已完成3 期
Open Label Study (Phase III) of NS-32 in Patients with Iron Deficiency Anemia Associated with Gastrointestinal Diseases
ippon Shinyaku Co., Ltd.0 个研究点目标入组 40 人开始时间: 2019年1月10日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
There was a significant difference in the maximum change in hemoglobin concentration from baseline for the primary endpoint. The same results were seen in both the NS-32 bolus and drip groups. Related TEAEs reported in >=5% of subjects in the overall population were hypophosphatemia, urticaria, and pyrexia. All events were mild or moderate and all resolved. These related TEAEs were effectively managed with standard treatment.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable(—)
- 性别
- All
入选标准
- •Patients confirmed with gastrointestinal bleeding due to gastrointestinal diseases and diagnosed with IDA
排除标准
- •Patients with anemia due to causes other than iron deficiency
研究者
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